IV set system with bypass manifold

ABSTRACT

An intravenous (IV) set system comprising a primary IV set defining a primary flow line of the IV set system. The primary flow line can include multiple access points along its length and feeds to a merging fluid pathway proximate to the distal terminus of the primary IV set. At least one secondary IV set with corresponding flow lines can be separably joined to the primary IV set to cause the secondary flow lines to be in fluid communication with the primary flow line. At least one of the IV sets can have a unique set of uniform marking indicia to facilitate rapid identification of the IV sets from other IV sets within the IV set system. Such marked and identified primary and/or secondary IV sets can be allocated to specific medical functions and/or can be for use by specific medical personnel to thereby minimize risk of error in administration of an IV to a patient. The IV set system can further comprise a merging fluid pathway about a primary IV set.

RELATED APPLICATIONS

This is a continuation application of U.S. application Ser. No.14/458,229, filed Aug. 12, 2014, entitled IV Set System with BypassManifold which claims the benefit of U.S. Provisional Application Ser.No. 61/864,977, filed Aug. 12, 2013, and entitled, “Multiline IV SetWith Coded, Strippable Components,” which application is incorporated byreference herein in its entirety.

BACKGROUND

One of the major benchmarks of medical care was the introduction of anIntravenous (IV) set to access the circulatory system of a patient,enabling the administration of fluids and medications in a controlled,predictable manner. The typical IV set includes a primary fluid flowline of tubular construction with one or more access points. Some ofthese access points can comprise access ports that allow theadministration of medications through either a syringe by push or byinfusion through another IV set (primary or secondary). A primary accesspoint is located at one end of the IV set with a fluid source, such asnormal saline or some other carrier fluid. A spike and drip chamberassembly is positioned at a terminus or proximal end of the flow linewith means for attachment to a patient injection site on a distal end.Secondary flow lines may be combined with the primary flow line withsimilar construction options.

Use of IV sets has now become ubiquitous at every stage of medical care,from the site of an accident or injury, through transport to thehospital, during emergency room and surgical procedures and potentiallycontinuing into the ICU and general hospital care. At each successivestage of procedure or treatment, different medical personnel typicallybecome involved. Normally, later stage medical personnel will not haveactual firsthand experience with a patient and the various multipleattached IV sets. Often, they may have to guess as to the purpose andprocedure associated with each previous IV set, including whatmedications may have been administered. Usually, some form of record oridentification is written or provided with respect to each IV set, theapplied medications, and various details regarding patient care. Usuallythis is in the form of a medical chart that accompanies the patient,providing a history of such procedures. Unfortunately, there may beconfusion as to the specific procedures applied with respect to an IVset based upon lack of proper interpretation or inaccuracy ofdescription.

When multiple medical personnel are involved, the combinations ofprocedures involving the multiple IV sets become even more complex. Thisis particularly true with respect to surgical procedures in an operatingroom. In addition to the surgical staff having to focus on specificmedical problems, other personnel may be involved, such as an anesthesiaprovider who typically administers anesthesia medications via the IVset. From an anesthesia provider's view, one primary concern can involvedetermining; which IV set has the carrier fluid that he/she can use topush any needed medication (i.e., which IV set, including spike/dripchamber, goes directly to the patient).

In the operating room, or during transport to and from the operatingroom, the anesthesia provider must be prepared and able to quicklymodify medication levels as required by hemodynamic changes in thepatient's state of being, as well as anesthesia demands and unexpectedemergencies. Confusion as to the correct identity of a given IV set canbe a serious risk to the patient and a great frustration to attendingmedical personnel. The general absence of standardized labels,standardized positioning requirements along the IV sets, and inadequateIV port or access identification present an ongoing medical risk.

In addition, there are inherently many basic problems associated withthe general use of current IV sets in any given situation. For example,constant concerns exist with respect to the proper introduction of amedication at an access point, the rate of fluid delivery through theflow line, the adequacy of mixture of medications within the IV set(s),the delay in transit time of a particular medication to the injectionsite, the amount of fluid in the flow line ahead of a newly administereddrug, and maintenance of a clean and functional injection site with thepatient. When multiple IV sets are combined these various problems aremagnified in complexity because of the increased amount of medicationsand hardware used as part of the compilation of IV sets, as well as thediverse medical personnel monitoring the same compilation of IV sets.

The participation of numerous personnel using the same compilation of IVsets often results in competition for physical access by the user toaccess ports, control of delivery rates with valves, makingmodifications in the respective IV sets, etc. Maintaining convenientaccess to the correct IV set and ensuring proper line identification isthe responsibility of each individual attempting to utilize the IV setat the same time. This competition for immediate access by multipleusers can add considerable additional stress to an already stressfulenvironment.

These problems take on a new dimension of risk in the more dynamicenvironment of an operating room, where decisions must be madeimmediately and acted upon under conditions of great urgency. Eachmember of the medical team must be assured of quick and certain accessto the component IV set(s) associated with his or her area of attentionand responsibility. In addition to proper identification of an IV set,each individual must be capable of accessing the access points and otherstructural aspects of the IV set or compilation of IV sets foradministering the required medication or procedure, without interferingwith the activities of other medical personnel attending to the patientthrough the same IV set or compilation of IV sets.

To meet these needs, various temporary and rudimentary methods ofidentifying individual IV sets and of bundling these together to avoidentanglement have been applied. For example, individual IV sets may betagged or labeled at a single site by the attending physician or otherpersonnel to identify its purpose. However, there is no standardizationof such practices, thus leading to confusion and wasted time spentlooking up and down the IV set for identification. Other attempts atline identification have included coloring the actual IV set itself.This may be a problem, however, because medications are often coloredthemselves. For example, a yellow IV set containing therein a cancermedication that is blue could provide a misrepresentative or falseappearance in the form of a green IV set.

To avoid entanglement, the various IV sets may be taped together orotherwise generally clipped into a bundle. This grouping of multiple IVsets with intermittent access ports, however, may become very confusingto multiple users of the compilation of IV sets, and is also very timeconsuming. Access points allow the various attending personnel toadminister medications through a syringe by push or by infusion throughan additional IV set. Not only does this additional structure add to thecomplexity of the compilation of IV sets with respect to possible lineentanglement, but it also limits access for the practitioner using amore proximal access port. For example, when a fluid restriction isbeing observed (e.g., pediatrics, kidney failure, or complex surgerycase), pushing a medication through an access point far from the patientbecomes a problem. Boluses of fluid must be administered to deliver themedication from the proximal access points to a distal end terminatingat the patient.

In view of these ongoing problems, medical personnel continue to make adhoc adaptations in an effort to mitigate the confusion associated withcurrent IV set practices. Despite these various solutions, current useof IV sets still requires considerable patience and a high degree ofattention on the part of medical personnel to deal with the ongoingdifficulties associated with such current IV sets. Past improvements inIV set technology seem to have been focused on isolated solutions todistinct or different problems, thus lacking in more general andcombined resolutions of such problems, and even creating new issues insome instances.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the invention will be apparent from thedetailed description which follows, taken in conjunction with theaccompanying drawings, which together illustrate, by way of example,features of the invention; and wherein:

FIG. 1 illustrates a plan view of an IV system in accordance with oneexemplary embodiment of the present invention;

FIG. 2A illustrates a partial plan view of the exemplary IV set systemof FIG. 1, and particularly one exemplary embodiment of a merging fluidpathway for the IV set system;

FIG. 2B illustrates a partial plan view of the exemplary IV set systemof FIG. 1, with an alternative merging fluid pathway and access portconfiguration;

FIG. 3A illustrates a plan view of an IV set system in accordance withanother exemplary embodiment of the present invention, the IV set systemhaving several example embodiments of marking indicia;

FIG. 3B illustrates a partial plan view of the IV set system of FIG. 3A;

FIG. 3C illustrates a partial plan view of the IV set system of FIG. 3A;

FIG. 3D illustrates a partial side view of the IV set system of FIG. 3A;

FIG. 4a illustrates a partial plan view of an IV set system comprising aplurality of integral inter-attached lines having a strippable property,in accordance with one exemplary embodiment of the present invention;

FIG. 4 b illustrates a partial plan view of an IV set system comprisinga plurality of integral inter-attached lines having a strippableproperty, in accordance with another exemplary embodiment;

FIGS. 5a and 5b illustrate respective cross-sections of the exemplary IVset systems of FIGS. 4a and 4 b;

FIG. 6a illustrates a cross-sectional view of an IV set system havingthe secondary IV sets oriented and arranged with respect to the primaryflow line of the primary IV set of the IV set system, in accordance withone exemplary configuration and embodiment of the present invention;

FIG. 6b illustrates a cross-sectional view of an IV set system havingthe secondary. IV sets oriented and arranged with respect to the primaryflow line of the primary IV set of the IV set system, in accordance withanother exemplary configuration and embodiment of the present invention;

FIG. 7A illustrates a partial plan view of an IV set system having amanifold bypass device in use with a primary flow line of a primary IVset, in accordance with one exemplary embodiment of the presentinvention;

FIG. 7B illustrates a partial plan view of the IV set of FIG. 7A, the IVset comprising a manifold configuration in accordance with an exemplaryalternative configuration; and

FIG. 7C illustrates a partial plan view of the IV set of FIG. 7A, the IVset comprising a manifold configuration in accordance with still anotherexemplary alternative configuration.

DETAILED DESCRIPTION

As used herein, the term “substantially” refers to the complete ornearly complete extent or degree of an action, characteristic, property,state, structure, item, or result. For example, an object that is“substantially” enclosed would mean that the object is either completelyenclosed or nearly completely enclosed. The exact allowable degree ofdeviation from absolute completeness may in some cases depend on thespecific context. However, generally speaking the nearness of completionwill be so as to have the same overall result as if absolute and totalcompletion were obtained. The use of “substantially” is equallyapplicable when used in a negative connotation to refer to the completeor near complete lack of an action, characteristic, property, state,structure, item, or result.

As used herein, “adjacent” refers to the proximity of two structures orelements. Particularly, elements that are identified as being “adjacent”may be either abutting; or connected. Such elements may also be near orclose to each other without necessarily contacting each other. The exactdegree of proximity may in some cases depend on the specific context.

An initial overview of technology embodiments is provided below and thenspecific technology embodiments are described in summary and in furtherdetail later. This initial summary is intended to aid readers inunderstanding the technology more quickly, but is not intended toidentify key features or essential features of the technology, nor is itintended to limit the scope of the subject matter.

At the outset, an IV set is intended to mean a single IV line. An IV setsystem is intended to mean at least a plurality of IV sets within the IVset system. The IV set system can comprise additional elements operablewithin the IV set, such as a merging fluid pathway, a manifold, variousaccess points, etc. An access point is intended to mean any point alongthe IV set in which access is provided to the fluid flow within the IVset. An access point can include such elements as access ports,spike/drip chambers, patient interconnect structures, fluid interconnectmeans, etc. An access port is intended to mean a specific type of accesspoint that facilitates access to the fluid flow within the IV set, suchas by push (e.g., using a syringe) or by infusion (e.g., through fluidcoupling of another IV set).

In considering current IV sets or compilation of IV sets and theevolution of these, the present inventors have noted that isolated andsegmented resolution of different perceived problems has failed toaddress many of the experienced problems discussed above. Indeed, manyof the individual solutions created over the past years have contributedto further difficulties in IV set identification and access. Therefore,instead of focusing on one or more isolated problems associated withcurrent IV sets, the present disclosure seeks to provide a moreextensive and encompassing solution that addresses a variety of problemsassociated with current IV sets, such as those discussed above. Thepresent IV set technology, as discussed herein, focuses, withoutlimitation, on meeting fluid delivery requirements, configuring orproviding multiple IV sets with indicia to aid in line identificationboth by fluid type and primary user, configuring one or more IV setswithin an IV set system to avoid entanglement of flow lines and toimprove user access, adapting an IV set with a manifold bypass componentfor regulating multiple fluid sources within the same IV set, providinga merging fluid pathway and optimizing the position of this, andexpanding the methodology of IV set technology to integrate amulti-stage, multi-care venue historical identification aspect.

These design aspects can be incorporated into various methods of useincluding (i) developing multiple venue utilization capability andprogressive records of use for a given IV set or IV set system as thepatient progresses through various stages of medical treatment, (ii)providing for retention of certain IV sets, or a link to their indicia,as part of a record of use, while programming deletion of other IV setshaving no historical value, and (iii) developing standard protocolswithin the medical field to expand utility of the IV set as a source ofpatient treatment information, as well as to further minimizemalpractice risks in patient care involving the administration of IVfluids and medications.

Historically, the use of the IV set has been segmented within variousprogressive stages of the patient experience. For example, at the sceneof an accident, paramedics may apply an IV set for temporary relief andapplication of emergency procedures. Upon arrival at the emergency room,a new IV set may be substituted upon identification of particular needsof the patient. Once the patient is stabilized and an initial diagnosisis made, changes may again be required in the IV set or the nowcompilation of IV sets. Eventually, the patient may be moved to ahospital ward for further treatment and evaluation. Once again, furthermodifications may be needed with respect to the patient's IV. If surgeryis ultimately required, the patient is typically prepared, whichpreparations can include additional modifications in IV set up as neededfor delivery of anesthesia and other required medications. Finally, uponcompletion of the surgery, the compilation of IV sets may again beadapted for normal hospital usage. As such, the reality of changingpatient environments and medical needs, coupled with the recognizedproblems associated with current IV set technology, calls for a dynamicIV set system and solution that can be adapted to meet the numerousrequirements of secure and reduced risk administration of IVmedications, as well as improved convenience of use for medicalpersonnel.

An IV set system in accordance with some exemplary embodiments of thepresent invention can comprise a primary IV set having a proximalterminus, a distal terminus, and an intermediate tubular length defininga primary flow line and primary fluid flow path of the primary IV set.The primary flow line can include multiple access points along itslength that facilitate access to the fluid pathway of the primary IVset, some of which can comprise access ports. The primary IV set canfurther comprise a merging; fluid pathway proximate to the distalterminus in fluid communication with the fluid flow path and the variousaccess points used to access the fluid flow path.

The IV set system can further comprise at least one secondary IV sethaving a secondary flow line. The secondary IV set can be removably andfluidly coupled to the primary IV set. For example, the secondary flowline can be secured to the primary flow line. The secondary IV set canalso include a proximal terminus, a distal terminus, and an intermediatetubular length. The proximal termini of each of the primary IV set andof the at least one secondary IV set can further include a couplingstructure for receiving a fluid source to be coupled to the IV setsystem for providing at least one fluid medium to a patient through theprimary IV set. The distal terminus of the at least one secondary IV setcan also include a fluid interconnect of various types andconfigurations for attaching the distal terminus of the secondary IVsets(s) to the primary IV set, such as via the merging fluid pathwaynear the distal terminus of the primary IV set. The distal terminus ofthe primary flow line of the primary IV set can provide a patientinterconnect for coupling the primary flow line of the primary IV set toa patient injection site. In accordance with one exemplary aspect of thepresent invention, the respective proximal terminus, access points, anddistal terminus of the primary IV set and each secondary IV set can havea unique set of marking; indicia to distinguish them from one anotherand other secondary flow lines.

The IV set system can further comprise one or more physically connectedIV sets. As such, another exemplary aspect of this invention can be tointegrally secure at least one secondary IV set to the primary IV set ina parallel relationship in at least a semi-continuous mannersubstantially along the intermediate tubular length of these. This canfunction to inhibit line entanglement within the IV set system. Stateddifferently, at least one secondary IV set can be physically removablycoupled to the primary IV set, and/or another secondary IV set, at oneor more locations external to the fluid flow paths of each. In otherwords, the tubular structures making up the respective IV sets anddefining the fluid flow paths therein can be physically coupled togetheralong their length. In one aspect, this can be achieved by joining orphysically linking the outer surfaces of the respective tubularstructures together in a continuous manner. In another aspect, this canbe done in a non-continuous manner. Moreover, the physical externalconnection of two IV sets can be done without interfering; with thefluid flow paths of any of the IV sets. This physical connection of thevarious W sets within the IV set system is not to be mistaken for thepotential fluid connection between various IV sets within the IV setsystem. Indeed, it will be understood that the secondary IV sets canalso be removably fluidly coupled to the primary IV set, such that theirfluid flow paths are in communication with one another (i.e., the fluidflow paths can be caused to intersect or otherwise merge or cometogether).

By being removably physically coupled together, the secured tubularlengths or the secured IV sets can be ideally configured for fully orpartially peeling or stripping away from one another in a selectablefashion, such as only when needed or desired. In one example, one ormore secondary IV sets can be fully stripped from the primary IV set anddiscarded if not needed. In another example, secondary IV set(s) can beselectively partially stripped away from the primary IV set as needed ordesired to provide variable free lengths of the one or more secondary IVset(s), such as to facilitate fluidly connecting these to the primary IVset and establishing one or more secondary flow lines and correspondingflow paths with respect to the primary flow line and its correspondingflow path.

The primary IV set may also include a manifold device positionedproximate to the distal terminus of the primary IV set and mountedexternally to the primary flow line, wherein the manifold can beremovably coupled to the primary IV set and configured to be in fluidcommunication with the primary flow line of the primary IV set. Themanifold thus functions as an alternate flow line and corresponding flowpath configured to selectively bypass a specific segment of the primaryflow line and its corresponding flow path.

A method for utilizing the same IV set system across various stages ofpatient care associated with applications of multiple IV procedures cancomprise the steps of (a) selecting an IV set system having a primary IVset and one or more secondary IV sets integrally connected with theprimary line at one or more positions external to the fluid flow path ofeach; (h) attaching the IV set system to a patient during a first stageof medical care and starting IV flow using at least the primary IV set;and (c) optionally progressing through use of at least one successivestages of medical care, wherein at least one secondary IV set is used ineach stage and retained, or whose indicia is retained, as part of the IVset system for later identification of the medical care provided duringthe respective two successive stages.

A method for providing selective identification of at least one flowline within an intravenous (IV) set system having (i) a primary IV sethaving a proximal terminus, a distal terminus, and an intermediatetubular length defining a primary flow line of the IV set system, and(ii) at least one secondary IV set defining at least one secondary flowline configured to feed to the primary flow line, the at least onesecondary line having a proximal terminus, a distal terminus, and anintermediate tubular length can comprise providing top-level markingindicia on the primary IV set; and providing marking indicia on thesecondary IV set different from the top-level marking indicia on theprimary IV set. The method can further comprise providing second-levelmarking indicia on the primary IV set, wherein the second-level markingindicia of the primary IV set matches the marking indicia of thesecondary IV set providing a set of snatching indicia across IV setsproviding additional second-level marking indicia on the primary IV set,wherein the IV set system further comprises an additional secondary IVset operable with the primary or secondary IV sets, the additionalsecondary IV set comprising marking indicia that differs from thetop-level marking indicia of the primary set and the marking indicia onthe secondary IV set; matching the marking indicia on the additionalsecondary IV set with the additional second-level marking indicia on theprimary IV set; associating the second-level marking indicia on theprimary IV set with an access point of the primary IV set, andassociated the second-level marking indicia on the secondary IV set withan access point of the secondary IV set; and associating the variousmarking indicia of the primary and secondary IV sets with one of amedical procedure, a type of fluid or medication, a medical personnel, amedical condition and a combination of these.

A method for managing use of an IV set system having a primary IV setand at least one separably joined secondary IV sets can compriseinitiating application of an IV to a patient along a primary IV set;identifying a first secondary IV set of the IV set system foradministering a substance to the patient; at least partially strippingan upper end of the first secondary IV set from the IV set system toprovide a free, unattached end to facilitate proper access andpositioning thereof within the IV set system, while retaining anattached portion of the first secondary IV set, thereby reducinglikelihood of entanglement of the primary and secondary IV sets; andstripping a lower end of the secondary IV set and coupling it to anaccess port located proximate a distal terminus of the primary IV set.The method can further comprise completely stripping the secondary IVset from the IV set system following use.

A method for bypassing a primary flow path of a primary flow line withina primary IV set can comprise obtaining a primary IV set having aplurality of access points facilitating access to one or more fluidpathways of the primary IV set, at least some of the access pointscomprising access ports providing fluid access to a primary flow line ofthe primary IV set; diverting fluid from the primary flow line to abypass flow line of a manifold removably and externally coupled to theprimary IV set via the access ports, the manifold comprising one or moreaccess points that facilitate access to the bypass flow line; andproviding, through the manifold, an alternate primary flow path to aprimary flow path through the primary flow line. The method can furthercomprise selectively actuating a flow control valve operable toselectively occlude fluid flow through the primary flow line of theprimary IV set and to divert the fluid through the manifold and thebypass flow line; restoring fluid flow through the primary flow line ofthe primary IV set.

Pre-Coded IV Sets/Set Systems

Some exemplary embodiments of the present invention represent a changein perspective, endeavoring to actually anticipate and preserve somemeasure of historical data regarding use of the IV set system as part ofthe IV structure itself. For example, a multi-set IV set system can beapplied which is capable of being adapted for use in subsequentprocedures without discarding earlier components and applications of theIV set system. Specifically, various routine IV procedures can bestructurally encoded by incorporating a particular color, shape orappropriate identification to differentiate the various IV sets of theIV set system. These various IV sets can be selectively utilized atsequential stages of medical care of the patient. By making a quickinspection of the patient's IV set system, subsequent attendingpersonnel can quickly identify those procedures having been applied tothis patient under prior medical procedures simply by examining the IVset system and the various IV sets therein to see which IV sets wereused, how they were used, if they were used, etc.

In some aspects, to avoid inappropriate repeated use of a givensecondary IV set, that secondary IV set can be partially or completelystripped away from the primary IV set and discarded. Nevertheless, theidentity of the discarded secondary IV set can be preserved at theprimary IV set for future reference by configuring the IV sets, or theirvarious access points, to comprise matching indicia. More specifically,the secondary IV set(s), and/or their access points, can compriseindicia that matches indicia on the primary IV set. For example, theprimary IV set can comprise an access port operable to fluidly couple orinterconnect with a corresponding access point on a secondary IV set.The access port of the primary IV set can comprise indicia that matchesindicia on the access point of the secondary IV set. Therefore, in theevent the secondary IV set is discarded, corresponding or matchingindicia present on the remaining primary IV set can indicate theprevious presence of the discarded secondary IV set, which indicia canprovide useful historical data to medical personnel.

Providing pre-coded IV sets within the IV set system itself provides aninitial cue to patient information, the details of which are provided onthe patient chart. Providing pre-coded IV sets can also speed up thedecision process by increasing the awareness of medical personnel withrespect to the patient's treatment history. Of course, in order tominimize entanglement and confusion, some IV sets can be purposefullyadapted to be quickly stripped from the IV set system or renderedunusable when their historical value is nominal.

The use of individually distinguishable IV sets having standard uniquedesignations corresponding to standard IV procedures gives medicalpersonnel the ability to quickly select an appropriate IV set from amongthe various available marked IV sets within the IV set system. Forexample, the use of a coded IV set specifically reserved for painmedication among the plurality of IV sets within the IV set systemprovides the medical attendant with an immediate preference of choice inselecting an IV set for administering pain medication.

Accordingly, the development of pre-coded IV sets as part of an IV setsystem provides at least two significant advantages. First, such apractice would assist medical staff in quickly identifying previousprocedures applied to the patient, thereby increasing the level ofawareness of medical personnel to the patient's history. In addition,having multiple pre-coded IV sets available could simplify the selectionof an appropriate line for a current procedure. For example, with aknowledge of a specific, predetermined function of the IV set to beapplied, attending personnel can quickly identify the corresponding IVset which has that coded function. Many forms of identification can beapplied with respect to the individual sets of an IV set system. Thesemay include, but are not limited to, specific colors, shapes, tactileindicators or indices, tags or other indices that could be respectivelyallocated and standardized for medications associated with blood, painmedication, anesthesia, etc., as well as any others and/or combinationsof these.

Rather than having only a single IV set system for universalapplication, it may be desirable to develop specific groups of IV setsystems selected to correspond with particular medical conditions havingforeseeable IV requirements, to correspond with particular personnel, orto correspond to particular procedures. Surgical patients, for example,could be treated with a single IV set system specifically configured foruse by the anesthesia provider and other members of the surgical team.Other patients having unique conditions could have a unique IV setsystem specifically configured for procedures, such as an endoscopy,related to their specific conditions. By having IV set systemsspecifically configured or tailored to particular medical conditions,procedures or personnel, clarity and convenience are greatly enhanced.

IV Set/Access Point Identification

In current designs, primary IV sets contain multiple access points thatfacilitate access to one or more fluid pathways within the IV set. Forexample, IV sets comprise access points through which fluids (e.g.,medications) may be administered. It is standard practice that when anIV is started on a patient that a carrier fluid (normal saline is oneexample) will be attached and administered. Future medications areadministered through the access points along that primary IV set. Theseaccess points allow medications to be given over multifarious intervals(i.e. rapid administration of medications pushed through a syringe by apractitioner, additional IV sets added and medications given at a ratedetermined by the position of a roller clamp or more specifically by apump with a set rate, etc.) As additional IV sets are used with thisprimary (carrier) IV set and the growing compilation of IV sets, thepotential for miss-identification of access points belonging to theprimary IV set increases exponentially. For example, if a primary IV setcontains four access points, an additional or secondary IV set couldalso contain two, three, four or more access points. These additionalaccess points may be difficult to distinguish from those of the primaryIV set.

Confusion as to the correct identity of a given IV set within acompilation of IV sets can be a serious life threatening risk to thepatient and great frustration to attending medical personnel. In almostall medical situations involving the use of multiple IV sets with asingle patient, even the most vigilant practitioners must take valuabletime to differentiate the primacy/carrier IV set from other medicationIV sets. This difficulty is intensified in emergency and other highstress situations and environments where mistakes can be magnified orthe number of mistakes increased as decisions often need to be madeimmediately. With the possibility of potent medications being deliveredthrough secondary IV sets, an inadvertent bolus from a drug being pushedthrough these secondary medication IV sets could be lethal. In addition,there is the constant danger of mixing incompatible medications orfluids. It is necessary, therefore, to be constantly concerned withwhich access points go with which IV sets. The general absence ofstandardized labels and standardized positioning of these labels alongthe IV sets, as well as inadequate IV access point identification,presents an ongoing medical risk.

One exemplary embodiment of the present invention includes the additionof marking indicia on or about (in close proximity to) at least twoaccess points, and alternatively at or about each access point, of theprimary IV set. Such marking indicia can further be located on or atother locations along the primary IV set. The marking indicia functionto help locate and differentiate the primary IV set and its accesspoints from other secondary IV sets either initially present, or addedthroughout the healthcare delivery process. Accordingly, the primary IVset itself and/or the various access points along the primary IV set canbe configured with unique and marking indicia to distinguish it and theaccess points from other secondary IV sets to facilitate rapid lineidentification. Furthermore, both the proximal and distal termini,and/or the various access points, of each secondary IV set can also haveunique marking indicia different from the primary IV set and othersecondary IV sets to distinguish them for rapid identification ofpriming, connection and disconnection.

Specific exemplary methods and features of line identification caninclude the techniques and structures shown in FIGS. 1-2B. Specifically,an IV set system in accordance with an exemplary embodiment of thepresent invention can include a primary IV set 100 having a proximalterminus 102, a distal terminus 104, and an intermediate tubular length106 defining a primary flow line 108 of the primary IV set 100, such asfor providing saline carrier fluid. The primary flow line 108 can havemultiple access ports 110 along its length, such as for administeringvarious medications needed by the patient, facilitating coupling of anexternal manifold to establish a bypass flow line, and others. Theseaccess ports 110 can be self-sealing, meaning that they are capable offacilitating flow when in use, and prohibiting or sealing off flow whennot in use. The access ports 110 can comprise any type or can be usedfor any purpose as recognized by those skilled in the art. For example,the access ports 110 can be used to couple or removably couple a syringefor pushing fluid into the primary flow line 108, they can be used tocouple or removably couple a secondary IV set to facilitate infusion ofa fluid into the primary flow line 108, etc. In one example, the accessports 110 can comprise a first connector portion of an interconnect orconnector operable to couple with a second connector portion of theinterconnect or connector. In the example shown, the access ports 110each comprise a first connector portion 132 in the form of a femaleportion of a Luer Lock. The secondary IV sets each comprise a secondconnector portion 133 in the form of a male portion of a Luer Lock.

The IV set system can further comprise at least one secondary IV set(e.g., see secondary IV sets 116, 118, 120) physically and removablycoupled to the primary IV set 100, such as via access ports 110. The oneor more secondary IV sets 116, 118 and 120 can further be removably andfluidly coupled to the primary IV set 100 via the one or more accessports 110 of the primary IV set 100, such as via those forming themerging fluid pathway 154, wherein the fluid flow paths of the secondaryIV sets 116, 118 and 120 and the primary IV set 100 are in fluidcommunication with one another, or in other words, come together ormerge.

The IV set system can further comprise a merging fluid pathway 154comprised of at least one access port 110 on the primary IV set 100. Themerging fluid pathway 154 can be positioned on the primary IV set 100about the primary flow line 108 proximate to the distal terminus 104 tominimize the amount of fluid in the primary IV set between the mergingfluid pathway and the patient interconnect. The access ports 110 of themerging fluid pathway 154 can be spaced at a predetermined distance fromeach other about the primary IV set 100. In the example shown in FIG.2A, the access ports 110 can be oriented at a 90-degree orientationrelative to the primary flow line 108. As one skilled in the art willrecognize, other angular orientations may be used where merited by thecircumstances, such as angular orientations between 30 and 150 degrees(as measured from the longitudinal axis of the primary line 500), oreven others. For example, FIG. 2B illustrates that the IV set system ofFIGS. 1 and 2A can comprise an alternative configuration of a mergingfluid pathway. In this example, the merging fluid pathway 154′ comprisesaccess ports 110′ oriented on about a 30 degree orientation relative tothe primary flow line 108′ of the primary IV set 100. This orientationwill likely provide smoother flow transitions of fluids from thesecondary IV sets 116′, 118′, and 120′, shown as being fluidly coupledto the primary TV set 100′, into the flow path of the primary IV set100′ over the configuration of the access ports 110 shown in FIGS. 1 and2A oriented on a 90 degree orientation.

In one example, the one or more secondary IV sets 116, 118 and 120 canby physically and separably connected to the primary IV set and/or oneanother. As such, the secondary IV sets 116, 118 and 120 can beconfigured to be stripped or peeled away from the primary IV set 100 asneeded as desired. This concept is discussed in greater detail below.Each secondary IV set can comprise a proximal terminus 122, a distalterminus 124, and an intermediate tubular length 126.

Current methods and materials for fluidly interconnecting IV sets andcouplings are well known and are not further described, except wheremodifications are particularly noted as part of the invention. Forexample, the proximal termini of the primary IV set 100 and the one ormore secondary lines can be adapted with a coupling structure 130 forreceiving a fluid source to be coupled to the IV set for providing atleast one fluid medium to a patient through the primary IV set 100.Similarly, the distal terminus 124 of the one or more secondary line(s)can include fluid interconnect means 132 for attaching the distalterminus 124 of the one or more secondary lines to one of the accessports 110 of the merging fluid pathway 154 near the distal terminus 104of the primary IV set 100. Finally, the distal terminus 104 of theprimary IV set 100 can further include a patient interconnect structure134 for coupling the primary flow line 108 of the IV set to a patientinjection site 114.

The merging fluid pathway 154 can comprise at least one accessport/fluid interconnect in direct fluid communication with the primaryflow line 108 of the primary IV set 100. The merging fluid pathway 154can be located anywhere along the primary IV set 100. In one aspect, themerging fluid pathway 154 can be located on the primary IV set 100 belowa midpoint of the primary IV set 100. In another aspect, the mergingfluid pathway 154 can be located on the primary IV set 100 at or nearthe distal terminus 104 of the primary IV set 100. In a more specificaspect, the merging fluid pathway 154 can comprise the distal mostaccess ports/fluid interconnects of the primary IV set 100, such asthose access ports 110 shown in FIG. 2A. These can be configured tocouple with the distal termini of the one or more secondary IV sets(e.g., IV sets 116, 118 and 120 of FIG. 2a ) to facilitate fluid flowfrom the one or more secondary IV sets directly into the fluid pathwayin the primary IV set 100. Generally speaking, the merging fluid pathway154 can provide a merging of fluid from the fluid source (e.g.,secondary IV set, syringe, etc.) connected to it directly with the fluidof the primary IV set 100.

In one example, being located at or near the distal terminus 104 of theprimary IV set 100, the merging fluid pathway 154 can provide a finalstage of fluid injection or infusion to the primary flow line 108 of theprimary IV set 100 prior to the point of attachment of the primacy IVset 100 to the patient at injection site 114. This final stage may alsobe followed by a final segment of flow along the distal terminus 104 ofthe primary IV set 100 to facilitate the merging of fluids within theprimary flow line 108 immediately prior to injection into the patient.This is likely an ideal position for coupling one or more secondary IVsets (e.g., secondary IV sets 116, 118, 120) and fluidly connectingtheir respective flow lines because it allows merging of other fluidsand medications into the primary flow line 108 proximate to the patientinjection site 114. The location of the merging fluid pathway 154proximate to the patient injection site 114 has many benefits, as taughtherein, and as will be recognized by those skilled in the art. Forexample, and not intending to be limiting in any way, these benefits caninclude precise timing of medications, rapid drug response due tolocation just proximate to IV insertion site, thus avoiding delays indelivery of medication to the patient, strict control of fluid volume,the ability to disconnect secondary lines leaving minimal amount ofmedication in the primary line, and the ability to disconnect andreconnect to the merging fluid pathway 154 during a patientsmulti-staged care. In addition, this configuration provides increasedhemodynamic stability independent of change to the rate of flow throughthe primary flow line 108. This merging fluid pathway 154 may bearranged in a unilateral orientation (extending in the same directionwithin a common plane), bilateral (extending in opposing directions)(e.g., see FIG. 2) or circumferential arrangement (extending radiallyoutward). The placement of this merging fluid pathway 154 can providethe caregiver with many options for both fluid management and medicationdelivery control.

In other embodiments, each of the proximal terminus, access points, anddistal terminus of the primary IV set 100 can include one or more uniquemarking indicia to distinguish the primary IV set 100 (an its accesspoints) from one or more secondary IV sets, and to facilitate rapid lineidentification for each IV set within the IV set system. The markingindicia can be uniform, or configured in accordance with some otherarrangement. Any slide clamps, roller clamps, or other elementsassociated with the primary IV set 100 can comprise the same indicia asthe other indicia on the primary IV set 100. Similarly, the respectiveproximal terminus, access points, and distal terminus of any or allsecondary IV sets can include one or more unique marking indicia todistinguish it from other secondary IV sets and the primary IV set thatmay have differing indicia. These too can be uniform or configured inaccordance with some other arrangement. Still further, the primary IVset 100 can comprise both top-level and second-level marking indicia,wherein the second-level marking indicia matches the marking indicia ona secondary IV set operable with the primary IV set 100. These conceptsare explained in more detail below with respect to other embodiments,although applicable and contemplated for use with the IV set system ofFIGS. 1-2B. In other words, the present description pertaining to codingof the various IV sets within an IV set system is applicable to the IVset system of FIGS. 1-2B, even if such description is in relation toanother embodiment. Essentially, the IV set system illustrated in FIGS.1-2B can comprise marking indicia as set forth and described in any ofthe embodiments discussed herein, as will be recognized and as can beapplied by one of ordinary skill in the art.

The IV set system of FIGS. 1-2B can further comprise individual IV sets(primary and one or more secondary IV sets) that are physically andseparably joined together in at least a semi-continuous mannersubstantially along their length, such as by attachment members 160, toinhibit entanglement with one another. In some aspects, the IV setsseparably joined together in a manner that facilitates partial or fullstripping of one IV set from another IV set. It is contemplated hereinthat the IV set system of FIGS. 1-2B can comprise separably joined IVsets as set forth and described in any of the embodiments discussedherein, as will be recognized and as can be applied by one of ordinaryskill in the art.

The IV set system of FIGS. 1-2B can further comprise a manifold 140externally coupled to the primary IV set via at least some of the accessports of the primary IV set, the manifold comprising a bypass flow lineadjacent the primary flow line, and one or more access points thatfacilitate access to the bypass flow line, wherein the manifold and thebypass flow line provide an alternate primary flow path to a primaryflow path through the primary flow line. It is contemplated herein thatthe IV set system of FIGS. 1-2B can comprise a bypass manifold as setforth and described in any of the embodiments discussed herein, as willbe recognized and as can be applied by one of ordinary skill in the art.

FIG. 3A illustrates an IV set system in accordance with another exampleof the present disclosure. The IV set system in FIG. 3A is similar inmany respects to the IV set system illustrated in FIGS. 1-2B in that itcan comprise many of the same elements. As such, the discussion abovewith respect to the example IV set system of FIGS. 1-2B is applicable tothe IV set system of FIG. 3A unless otherwise noted. Like the IV setsystem in FIGS. 1-2B, the IV set system in FIG. 3A comprises a pluralityof secondary IV sets attached to a primary IV set 200. The IV set systemof FIG. 3A can further comprise a merging fluid pathway 254 as set forthand described in any of the embodiments discussed herein, as will berecognized and as can be applied by one of ordinary skill in the art.The IV set system of FIG. 3A can further comprise a bypass manifold 240as set forth and described in any of the embodiments discussed herein,as will be recognized and as can be applied by one of ordinary skill inthe art.

With respect to the concept of marking indicia, in the example shown,the secondary IV set 216 is shown as being distinguishable from theother secondary IV set and the primary IV set 200 by clearly markedindicia, namely circular rings 238, located at both the proximal anddistal termini of the secondary IV set 216. In one aspect, the primaryIV set 200 can comprise its own, different marking indicia, as discussedabove. For example, along the primary IV set 200 the spike structure 230above the drip chamber 242, as well as the various access ports 210, canhave a different set of marking indicia that distinguishes the primaryIV set 200 from any of the secondary IV sets.

In one embodiment, these marking indicia can form part of the originalconstruction of the respective lines of the IV set, being fabricated aspart of the original structure. These marking indicia may include, butare not limited to texture, color and shape. Alternatively, the markingindicia can be manufactured independent of the IV sets, and laterapplied or otherwise associated with the various primary and secondaryIV sets of the IV set system subsequent to their initial manufacture.There are a variety of ways and means by which the marking indicia canbe associated with the lines in the IV set system, as will be recognizedby those skilled in the art. For example, the marking indicia cancomprise various objects, indicators, etc. that can be applied orotherwise associated with the various lines of the IV set system usingadhesives, clamps, snap-on systems, fasteners, etc. Such marking indiciamay also include color, geometric shape, size and texture, or any othertactile and/or visual element that can enable the attending personnel toquickly and accurately identify a given IV set within the IV set system.

With reference to FIGS. 3A-3B, each of the IV sets, including spikes,drip chambers, access ports, proximal and distal termini, clamps, etc.,can comprise top-level indicia, identified as top-level indicia “TL,”specific to that particular IV set, yet different from the top-levelindicia of surrounding IV sets. In other words, each IV set in the IVset system can comprise a different set of top-level indicia, which canbe uniform (the same), wherein their primary function is to identify anddistinguish each IV set from any other IV set in the IV set system. Inthe example shown, the primary IV set 200 comprises top-level indiciaTL_(P) at the proximal and distal termini. Furthermore, the primary line200 comprises top-level indicia TL_(P) along its length. The top-levelindicia can be uniform about the length of the primary IV set 200.Specifically, the primary IV set 200 comprises top-level indicia TL_(P)in the form of a plurality of spherical shaped objects 244 located atthe proximal and distal termini, as well as at or near the drip chamber242, and access ports 210. The spherical objects 244 can furthercomprise additional indicia, such as a textured surface (see pattern ofbumps 246 formed thereon). Numerous variations in colors, shapes andtextures can be employed. Alternatively, the primary IV set 200 cancomprise top-level indicia located directly on each of its accesspoints, such as the access ports 210 (e.g., the access ports 210comprising a distinguishing color).

The secondary IV sets 216 and 218 physically and fluidly coupled to theprimary IV set 200 can also comprise top-level indicia “TL_(S1)” and“TL_(S2),” respectively, which can be uniform about the length of thesecondary IV sets 216 and 218. Specifically, in the example shown,secondary IV set 216 comprises top-level indicia TL_(S1) in the form ofcircular rings located at the distal termini, and secondary IV set 218comprises top-level indicia TL_(S2) in the form of colored adhesivestrips 252. Secondary IV sets 216 and 218 can alternatively comprisetop-level indicia directly on each of its access points, such as theinterconnects on the proximal and distal termini. In another example,and although the drawings illustrate the secondary IV sets 216, 218 ascomprising indicia, it is contemplated that the secondary IV sets 216,218 can be devoid of indicia, wherein if used with the primary IV set200 these two IV sets will be distinguishable from one another.

With reference to FIGS. 3A-3D, each of the primary and secondary IV setswithin the IV set system can each further comprise one or moresecond-level marking indicia, wherein the second-level marking indiciafrom one IV set can be configured to match with a correspondingsecond-level indicia of another IV set, thus providing a set of matchingindicia across IV sets. In one example, the matching indicia can operateto provide a particular identifying trait or feature pertaining to theassociated IV sets. In the example shown, the primary IV set 200comprises second-level indicia “2L_(P)” located on a nipple 211 of anaccess port 210 operable to fluidly and removably couple with aninterconnect portion 233 located on the distal termini of the secondaryIV set 218, thus the matching second-level marking indicia is intendedto be located on or about or in close proximity to two access points ofthe primary and secondary IV sets that correspond with or that areintended to correspond with one another (e.g., the fluid coupling of anaccess point on the secondary IV set with a particular access port onthe primary IV set). Likewise, the secondary IV set 218 is shown ascomprising second-level indicia “2L_(S2)” on the interconnect 233 thatcouples to the access port 210. The second-level indicia of the primaryIV set 200 can be configured to match the second-level indicia of thesecondary IV set 218 at the location where the secondary IV set 218couples to the primary IV set 200. For example, the second-level indicia2L_(P) and 2L_(S2) can be colored coded to comprise the same color. Inthis example, with the secondary IV set 218 coupled to the primary IVset 200, the second-level indicia of the primary IV set 200 isconcealed, thus maintaining the uniformity of indicia about the primaryIV set 200 by way of the top-level indicia thereon. However, in thosesituations where the secondary IV set 218 is not coupled to the primaryIV set 200, or removed therefrom, the second-level indicia of theprimary IV set 200 will be visible to attending medical personnel. Withthe second-level indicia 2L_(P) on the primary IV set 200 visible,medical personnel can quickly and easily perform line identification andother tasks, as well as possibly being provided with historical datapertaining to the use of the IV set system. Matching indicia present onthe remaining primary line can indicate the previous presence of theparticular secondary IV set 218. Those skilled in the art will recognizethat the second-level indicia 2L_(S2) on the secondary IV set 218 canfunction as a top-level indicia. In this case, it is contemplated thatthe secondary IV set 218 will only comprise only a single level ofmarking indicia, namely indicia that matches the second-level indicia onthe primary IV set 200. Those skilled in the art will also recognizethat secondary IV set 216 operable with the primary IV set 200 can alsocomprise its own top-level and/or second-level indicia different fromthat of the first secondary IV set, and that matches differentsecond-level indicia on the primary IV set 200, such as that associatedwith another access port 210.

The use of multiple or different indicia (e.g., including one or more ofshape, size, color and texture) will enhance the sure identification ofthe various IV sets. Furthermore, by standardizing specific indicia forcommon IV applications (e.g., standardizing indicia types), experienceand common usage will further enable rapid identification. For examplethe following general IV applications might be associated with thefollowing marking indicia types:

a. Vasopressors indicia type one (e.g., purple)

b. Paralytics—indicia type two (e.g., red)

c. Narcotics—indicia type three (e.g., blue)

The marking indicia can be further coordinated to represent a group ofmedical IV procedures corresponding to a particular medical condition orprocedure. In this manner, medical specialists can become accustomed tothe regular and exclusive use of particular indicia associated withtheir field of medicine. Such examples can include:

a. Chemotherapy—colored strips or other annular indicia. (See coloredadhesive strips 252).

b. Endoscopy—bumps

In this manner, progressive advancement of each patient type through agiven set of procedures can be historically recorded within the IV setsystem of the patient. Attending medical personnel can also be assistedin making a correct selection of an IV set in any given procedure basedon the IV code identification, rather than merely making randomselection of a line from a bundled IV set. An overall advantage of sucha system can be to contribute to improved organization and access to therespective IV sets, as well as improved predictability in theadministration of an IV. It will be apparent to those skilled in the artthat the concepts of unique identification set forth in this applicationcan be modified in various ways without departing from the invention.

Strippable IV Sets as Part of a Separably Attached IV Set System

IV line entanglement is also a major concern in any tertiary carefacility. Not only is safety a concern, but time and ease of managementfor practitioners in these environments is also a worry. As an exampleof benefits associated with the present invention utilizing, forexample, color or other indicia coded components, consider a typicalexperience of a 70 year-old patient arriving at the emergency departmentwith a fracture of the femur. On being admitted, it is determinedsurgery will be necessary. Suppose the patient has a history ofhypertension, coronary artery disease and is a non-insulin dependentdiabetic. Knowing this, an appropriate IV set system having physicallyremovably coupled and integrated multiple flow lines having variousmarking indicia thereon can be selected for the patient. Using amulti-set system with indicia coded lines for the respective potentialmedications and fluids for this patient provides familiar IV set systemchoices for each attending medical person. The present disclosurecontemplates and the described invention facilitates use of a single IVset system for the length of the stay and across multiple stages ofcare.

The selection process can include an awareness of the patient's existingco-morbidities. In this hypothetical situation, a three-set (e.g., oneprimary and two secondary IV sets) within the IV set system can beutilized for IV management. The main or primary IV set can be used forIV fluids and to push medication administration to the patient injectionsite. The two secondary IV sets can be available for IV drip ormedication infusions as needed. The patient can then be prepped for theoperating room using this single IV set system.

Upon arrival at the operating room the anesthesia provider can quicklyvisually inspect and interrogate the IV set system and its coded IV setsand corresponding flow lines and identify or determine which line is tobe used for administering general anesthesia. In the event at some pointthe patient becomes hypotensive and a vasoactive medication drip needsto be administered through one of the secondary IV sets, one of thesecomponents of the IV set system can also already be available for useand easily identifiable with its distinguishable marking indicia. Aninsulin drip can be on standby and ready for use to be administeredthrough the remaining secondary IV set if needed. Furthermore, in theevent the patient stays overnight in the surgical ward, and when thepatient stabilizes, it is likely that the insulin and vasoactivemedications will no longer be needed. As such, before leaving theoperating room, the anesthesia provider can stop the additionalinfusions and strip away or remove one or more of the two secondary IVsets from the other secondary IV sets and/or the primary IV set, whichcan remain intact for use on the surgical ward. As can be seen, the useof coded IV sets can avoid the prior known difficulties of selection inthe various medical situations encountered.

Simplifying the process of IV set selection and maintenance, allows themedical staff to avoid unnecessary intermingling of the various IV setswithin the IV set system that might otherwise lead to entanglement.Because the different IV sets are color coded (or otherwise uniquelymarked and identifiable), such as at the proximal and distal termini,and/or at or near access points along the intermediate sections, IV setsare more easily managed during use. Marking each IV set enablespersonnel to quickly and easily identify the various flow lines of theIV set system, maintain separate alignment of these IV sets, and avoidweaving and entangling the various lines amongst each other, thus easinguse of IV sets during medical situations, particularly during emergencyand other stressful situations. Otherwise, without clear identification,a user might grasp what he/she believes is the correct line,subsequently realize the error, and quickly attempt to take another lineand reposition it where needed. Eventually, these lines may becomeinterwoven, further complicating the correct identification.

One can also see that at each successive stage of a hospital stay, it ispossible that medical staff personnel can change, with newly attendingpersonal becoming involved with management of a patient's IV set system.When multiple medical personnel are involved, particularly when eachperson is dealing with different medical issues, the combinations ofprocedures involving the IV set system become even more complex. If thepatient from the above example experiences complications leading totransfer to the intensive care unit, multiple IV sets may becomeattached to one or more IV catheters inserted into the patient. Ifcurrent IV set types are added, these being without clear identificationmeans, and without inter-attachment of lines in an orderly manner, nomeans of controlling and physically organizing these IV sets wouldexist, leading to a confusing mass of fluid pathways often referred toas a “spaghetti pile”. If surgery is again needed, any additionalcurrent IV set types added to the patient's compilation of IV sets wouldincrease the entanglement problem. However, with the present IV setsystem the use of marking indicia (e.g., standardized marking indicia)on each IV set, and integrally coupled IV sets (see FIGS. 5 and 6), suchconfusing situations of line entanglement can be easily avoided.

The present invention can minimize problems of line entanglement byallowing IV sets to be physically joined or coupled together in aremovable manner. For example, each IV set system can comprise a primaryIV set and one or more secondary IV sets joined to the primary IV setand/or an additional secondary IV set. Additionally, each line of eachIV set can be properly coded for unique identification. Secondary IVsets can further be appropriately fluidly coupled to the primary IV set,providing a recognizable system for the attending personnel. As isexplained hereafter, a manifold coupling system can also be used withthe IV set system to simplify multiple stages of patient treatment. Ifmedical staff members are uncertain of the potential procedures to beapplied to a patient, an IV set system can be selected which includesphysically and separably joined or connected (e.g., integrally separablyconnected) IV sets for several likely procedures that could arise,enabling attending individuals to have immediate access to an existingIV set coupled to the patient. The versatility of pre-coded IV setsgrouped for pre-selection according to the anticipated needs of thepatient offers greater convenience, safety, and ultimate cost savingsover prior IV set solutions through reduction of errors and risks withinthe medical care arena.

As can be noted from the previous example, this invention is well suitedfor use in common or other medical situations or practices calling foran IV set up. The following four examples illustrate this concept, andare not intended to be limiting in any way.

Example 1—TIVA

A Total Intravenous Anesthetic or TIVA is the administration ofanesthesia utilizing IV medications as opposed to inhaled anesthetics tomaintain a general anesthetic. Common medications essential, but notlimited, to a TIVA are a hypnotic/sedative agent and narcotic agent.

Merging Fluid Pathway

The present IV set system is designed to facilitate and enhance thisanesthesia approach. In some example configurations, the merging fluidpathway (MFP) can be located on the primary IV set at or near the distalterminus. As indicated above, the MFP can comprise at least one accessport/fluid interconnect on the primary flow line in close proximity tothe distal terminus of one or more secondary IV set(s) to subsequentlybe fluidly coupled to the primary IV set. These secondary IV sets can bephysically and separably joined (e.g., integrally secured) to theprimary IV set in a parallel relationship in at least a semi-continuousmanner at least partially along their tubular length to inhibit lineentanglement, facilitate rapid line identification and gravity priming(see, for example, the representative methods of attachment between theprimary and secondary IV sets illustrated in FIGS. 5 and 6). Attachmentbetween IV sets maintains the respective lines in an orderly array, evenwhen several attending personnel are concurrently making use of the IVsystem for various procedures. Coding indicators on one or more of theselines enables rapid identification in accordance with the intendedpurpose for any given line and/or access port. The location of both thedistal terminus of the secondary line(s) and location of the mergingfluid passageway are ideal as they provide the caregiver with both asecondary medication line and an access point in close proximity to oneanother, wherein the secondary IV set can conveniently be fluidlycoupled to an access port of the merging fluid passageway. To summarize,some of the advantages of an IV system incorporating a merging fluidpathway as disclosed include the following:

1. The ability to administer medications at a distal location whilemaintaining hemodynamic stability regardless of flow rate changes in theprimary flow line;

2. The ability to discontinue one or more secondary lines with minimalresidual amounts of medication in the primary flow line, therebydecreasing the risk of an over dose; and

3. Allowance for rapid onset of any secondary medication(s) administeredthrough a secondary line due to the distal location of the MIP; evenwith slow primary flow rates.

Example 2—Endoscopic Procedures

During endoscopic procedures, anesthetic agents are often used tofacilitate scope and instrument placement and manipulation as well aspatient comfort. A sedative/hypnotic agent infused, using an IV pump viaa secondary IV line, into the primary IV line is often used as theprimary means of anesthesia. The present IV set system will allow asecondary IV set that is separably joined to a primary IV set as themeans of administrating the sedative/hypnotic agent. Advantages arereduced line entanglement and allowance for rapid onset of any secondarymedication(s) administered through a secondary IV set due to the distallocation of the MFP; even with slow primary flow rates.

Example 3—Complex Patient

Anesthesia for a complex patient involves administration of manydifferent medications, often simultaneously, and includes but is notlimited to sedative/hypnotics, narcotics, paralytics, insulin,vasopressors to manipulate blood pressure, and medications to supportheart rate, and contractility of the heart. IV access is often limitedso all these medications are run via secondary IV sets connected tosyringe and infusion pumps into a primary IV set that serves to deliverthe carrier fluid. Over fluidization, line entanglement and IV setidentification are constant problems encountered during these complexcases. With the limited number of access ports on currently availableprimary line IV sets, distal connection for these potent and potentiallylethal medication lines is an issue. Some embodiments of the present IVset system solve these problems and provide various advantages, such asallowance for rapid onset of any secondary medication(s) administeredthrough a secondary line due to the distal location of the MFP (evenwith slow primary flow rates), thus reducing total fluid requiredthrough the primary IV set limiting over fluidization; reduced lineentanglement and identification difficulty related to all secondary IVsets being separably connected to the primary IV set and having eachwith its own unique marking indicia to allow for rapid identification ofeach separate line; the ability to administer medications at a distallocation while maintaining hemodynamic stability regardless of flow ratechanges in the primary flow line; the ability to discontinue one or moresecondary IV sets with minimal residual amounts of medication in theprimary flow line, thereby decreasing the risk of an over dose; andothers as will be recognized by those skilled in the art. In accordancewith the present invention, the array of a plurality of secondary IVsets integrally connected in combination with a primary IV set avoidsthe inevitable entanglement of the various lines during patient care. IVset positioning remains orderly and predicable throughout the appliedprocedures by numerous medical personnel. Rapid identification of eachIV set with its designated function is facilitated by appropriatemarking indicia provided on the IV sets.

As indicated above, the present invention provides for separableattachment at least between the secondary IV sets of the IV set system,and also with the primary IV set as well. To further assist the medicalstaff to avoid the entanglement problems, as well as aid in comet andprompt identification of an appropriate IV set, the present inventionincorporates the ability to fully or partially strip one or moreseparably connected IV sets away from the other IV sets when they are nolonger needed or no longer serve a function. As such, it can be saidthat the IV set system, in some examples, can comprise one or more IVsets (primary, secondary, or both) that are separably connected to oneanother so as to be fully or partially separable or strippable. Thisproperty of “strip-ability” may be accomplished in several ways and withseveral types of construction. FIG. 3A illustrates the IV set system ascomprising attachment points 260 that physically separably join theprimary IV set 200 to the secondary IV sets 216 and 218. The IV setsystem illustrated in FIG. 3A can comprise separably joined IV sets asset forth and described in any of the embodiments discussed herein, aswill be recognized and as can be applied by one of ordinary skill in theart.

Different embodiments illustrating separably joined IV sets and theassociated strippable function are shown in FIGS. 4a and 4b . FIG. 4billustrates an IV set system similar to the one shown in FIG. 3. The IVset system of FIG. 4b is shown as comprising a primary IV set 400 andtwo secondary IV sets 416 and 418 that are separably and physicallyjoined together. In this particular example, the IV set system comprisesa discontinuous type of attachment of the primary IV set 400 and thesecondary lines 416 and 418 at fused locations 460 along the respectivetubular flow line structures. In other words, discontinuous, isolatedattachment members at fused locations 460 function to physically jointhe IV sets together. These attachment members at the various locations460 are considered to be discontinuous as they are separated byunconnected segments of the tubular flow line structures. The isolatedpoints of attachment or fused locations 460 can comprise materialintegrally formed from the same material as the IV lines, or they cancomprise a different material. In any event, the attachment members atfused locations 460 can comprise material that can facilitate thejoining of one or more IV sets, and the selective separation or peelingaway of these. In one aspect, the attachment members can be designed andconfigured to tear or rip. In another aspect, the attachment members canbe designed and configured to separate or pull away from at least one ofthe IV sets.

Alternatively, FIG. 4a illustrates an IV set system comprising a primaryIV set 300 and two secondary IV sets 316 and 318 having a continuousattachment member 362 between the primary IV set 300 and the secondaryIV sets 316 and 318 that functions to separably join these together. Inthis example, the attachment member 362 can be comprised of the samematerial as the primary or secondary lines, and thus be integrallyformed, or it can comprise a different material. The attachment member362 can be disposed between one or more joined IV sets in a continuousmanner, meaning that the IV sets are joined together withoutdisconnected or disjoined segments within the attachment member 362.This does not necessarily mean that the IV sets are joined togetheralong their entire length, although they could be. As such, the primaryIV set and/or the secondary IV set(s) may be attached in a continuousmanner along at least a portion of their length. Moreover, theattachment member 362 can be designed and configured to easily tear orrip, or alternatively pull away from one of the lines.

One skilled in the art will recognize other systems, means, devices ormethods in which the various lines in the IV set can be separablyconnected to one or more other lines in the IV set so as to facilitatethe strippable functionality as described herein.

Stripping the IV sets from one another can occur as needed or desired,such as when a coded IV set is no longer needed or has already been usedand therefore has no value (such as for historical purposes, foradministering medication, etc.). Under these types of circumstance, thepresence of any unnecessary IV sets can become a nuisance, interferingwith access to still needed or required IV sets, as well as addingunnecessary IV sets that must be distinguished from those still neededby the patient. By stripping away these unnecessary IV sets, the bundleof IV sets within the IV set system is reduced, thus making the IV setsystem more manageable.

More specifically, and with reference to FIGS. 4a and 5a , the exemplaryprimary IV set 300 and secondary IV sets 316 and 318 can be attached inan integral and continuous manner along all or a portion of theirlengths. In this example, the IV set system can comprise a materialportion or attachment member 362 disposed between the IV sets. In oneexample, the material portion 362 can comprise an extension of the samematerial as that used to form the tubular structures making up the IVsets. Stated differently, the tubular structures of the joined IV setscan be joined during their formation or manufacture. The tubularstructures can be configured to comprise an outer wall portion and aninner wall portion that defines the interior bore or lumen of thetubular structure. The tubular structures can further be configured tocomprise an extension portion extending from the outer walls betweenthem, the extension portion making up the attachment member 362. Theattachment member 362 can be configured to space the tubular structuresof the joined IV sets a given distance apart from one another.Furthermore, the attachment member 362 can be configured to comprise asuitable configuration (e.g., thickness, etc.) that will both maintain aproperly joined arrangement during use of the IV set system, while alsofacilitating selective strip-ability as needed or desired. A continuousjoining arrangement will allow the user to precisely control the amountof line to be stripped away.

Generally, as shown in FIGS. 4a and 5a , the at least one secondary IVsets 316, 318 can be secured to the primary IV set 300 in a parallelrelationship, each secondary IV set having a proximal terminus, a distalterminus, and an intermediate tubular length secured via the attachmentmember 362 to the primary IV set in a continuous manner substantiallyalong the intermediate tubular length to inhibit line entanglementwithin the IV set system. This secured attachment along the tubularlength is configured in a manner so as to facilitate the peeling away ofone or more secondary IV sets 316, 318 from the primary IV set 300 toprovide variable free lengths of the proximal secondary IV sets 316, 318as needed, such as for establishing secondary flow lines to the primaryIV set 300.

As an alternative to a continuously attached relationship between therespective IV sets, the at least one secondary IV set 416 may be securedto the primary IV set 400 and/or an adjacent secondary IV set 318 indiscontinuous fashion by employing discrete points of attachment 460, asillustrated in FIGS. 4b and 511. In this configuration, the discretesecured segments of the secondary IV sets 416, 418 can be separated bydiscontinuous, unsecured segments of lengths of the tubular structuresmaking up the IV sets to provide detectable stop points for peeling awaythe secondary IV sets 416, 418 at predetermined lengths. These stoppoints provide or define pre-formed lengths of line that can be strippedaway upon severing the attachment members, and will allow the user toconsciously determine how much of an IV set to strip. As an IV set ispulled free from an adjacent IV set, each point of attachment releases,allowing the user to choose to partially strip the line or to continueprogressively breaking each bond until the line is fully removed. Oneadvantage of a partial release is that attending medical personnel canhave a length of line now free from the IV set with another part of theline remaining joined. The now free length can be used for a variety ofpurposes, such as to connect to an additional saline or fluid bag, amedication infusion source, etc. The length of this free segment can bechosen by the attendant as needed.

By having discontinuous, discrete points of attachment spaced alongjoined IV sets, the unneeded lines can be removed with less appliedforce. To accomplish this, each attachment member 362 can be bonded orsecured at spaced intervals with material that can be easily pulled freefrom one or more of the joined IV sets, or torn without applyinginappropriate breakaway force that could jeopardize the integrity ofeither of the joined IV sets and/or maintenance of the IV sets in asecure relationship with the patient. In one example, the secondarylines 416, 418 may be secured to the primary line 400 in differingdiscrete segments having differentially secured lengths to provideoffset positions for access points along the length of the primary IVset. This configuration can assist personnel in avoiding the use ofcompeting space for their procedures by having the various access pointsof each IV set displaced from each other. Regardless of the method ofattachment, the IV sets can be configured to break free without undoforce so as to not disturb the patient access point. The integrity ofthe IV sets (leak-free, internal and external wall diameter,longitudinal stretching) can remain unaltered. Although the intention isto allow the IV sets to be stripped away from one another, the constructin which they are attached can be significant enough that they will beable to maintain form without inadvertent stripping.

FIGS. 6a and 6b further illustrate how the at least one secondary IVsets can be aligned in either a planar (linear) or a circumferentialarrangement with respect to the primary IV set or other attachedsecondary IV sets. With reference to FIGS. 1 and 6 a, secondary IV sets116, 118 and 120 are shown as being aligned in an exemplary parallel andcircumferential arrangement with respect to the primary IV set 100. Inthis example, the primary IV set 100 comprises a larger diameter thatfacilitates the attachment of the secondary lines 116, 118 and 120axially around the primary IV set 100 in parallel fashion, such as fromproximal to distal termini. With reference to FIGS. 1 and 6 b, thesecondary IV sets 116, 118 and 120, and the primary IV set 100, areshown as being aligned in an exemplary planar or linear arrangement inrelation to the primary IV set 100, and in parallel fashion, such asfrom proximal to distal termini.

The choice of alignment can depend upon several factors. The planar orlinear arrangement allows for a low profile. A low profile can be verydesirable when the IV set may come in contact with another object (e.g.,arms tucked at the patients side in the OR, patient in a lateralposition in the OR, etc.) This particular design does, however, restrictthe care provider from stripping away the interior secondary IV set ofthe inter-attached bundle of IV sets as it will be in contact with boththe primary IV set and other secondary IV sets. (See FIG. 6b ) Thecircumferential arrangement shown in FIG. 6a provides attending medicalpersonnel more options over the arrangement in FIG. 6b in regards tostripping away IV sets and customization. This arrangement does,however, increase the profile of the IV set system. FIGS. 6a and 6bfurther illustrate attachment members 162 separably coupling the primaryIV set 100 with the one or more secondary IV sets 116, 118, and 120.

In addition to the structural features set forth above, several optionsfor applying a disclosed method for using the strippable IV set withintegrally attached flow lines are illustrated below. Those personsskilled in the art will identify various methods and applications forthe featured structural embodiments set forth; however, several generalprocedures are specifically set forth. For example, the presentinvention includes a method for managing use of a primary IV set andmultiple, integrally and removably inter-attached secondary IV sets of abundled IV set system to minimize entanglement of the lines of the IVsets during use. This method can be generally described by the steps ofa) initiating application of the IV set system to a patient in acustomary manner using a primary flow line of a primary IV set. This maybe a carrier fluid such as saline or any other appropriate fluid medium.A second step (b) would be identifying a first secondary IV set of thebundled IV set system for administering a second substance to thepatient, such as a medication, and then at least partially stripping anupper end of the first secondary IV set from the primary IV and or asecondary IV set to provide a free, unattached end of the firstsecondary IV set. This free end facilitates proper access andpositioning of the line with respect to the IV set system in anorganized manner, while retaining an attached portion integral with thebundled IV sets to avoid entanglement with other IV sets. As anadditional step (c), a second secondary IV set may also be identifiedfor administering a third substance to the patient, such as a sedatingor anesthetizing agent. In a similar manner as with the first secondaryIV set, an upper end of this second secondary IV set is at leastpartially stripped to provide a free, unattached end to facilitateproper access and positioning thereof with respect to the IV set system,while retaining the attached portion of the line integral with the IVset, thereby reducing likelihood of entanglement of this line. A furtherstep (d) involves stripping lower ends of these secondary lines from oneor more IV sets within the IV set system, and then coupling them toaccess ports at the lower distal portion of the primary IV set, such asvia the merging fluid pathway. These first and second lines can then becoupled to appropriately administer solutions. When marked with uniqueindicia, each line can be clearly identifiable and quickly accessible toattending medical personnel. If desired, the attendant may completelystrip at least one of the first or second secondary IV sets free fromthe IV set system when one or more of those sets are no longer required,thus further simplifying the IV set system and reducing likelihood ofentanglement with other lines. In this case indicia matching indiciafrom that stripped IV set can remain or caused to be visible on theprimary IV set.

Multiline Manifold Attachment

In many settings throughout the hospital, healthcare providers oftenhave a need to quickly administer boluses of multiple medications. Thisneed may stem from patient condition, cumin procedure or both. Thischallenge is often met through the use of an injection port manifold,which consists of multiple injection ports organized in close proximity.Standard manifolds are part of the fluid pathway enabling injections tobe carried from the injection on the manifold site to the IV patientconnection. Manifold injection ports often contain a unidirectional flowapparatus enabling syringes to be left in connection to the port withoutfluid backflow into the syringe. Manifolds an also be composed of two ormore stopcocks permanently attached to one another.

The settings of the hospital are where an anesthesia providers practiceare especially prone to manifold utilization. Induction of anesthesiarequires the bolus injection of various medications in rapid succession.The timing of medication administration during the induction ofanesthesia coincides with the need for the anesthesia provider toexternally maintain the patient's airway and ventilation. This needmakes the use of a manifold especially helpful because it enables theprovider to inject medication at the manifold with one hand.

Current IV manifold sets are often bulky making their presenceundesirable in settings where their use is not needed. To overcome thischallenge, other current manifolds are often connected in-line with theprimary IV set utilizing, for example, an alternating male/female LuerLock system enabling the in-line manifold to be removed and theremaining primary IV set to be reattached. An important disadvantage ofthis in-line arrangement or configuration is the requirement to “break”or completely separate the fluid pathway, thus increasing the risk ofcontaminating the IV line and increasing the risk for infection.Manifolds are often used during the anesthesia portion of the hospitalstay and are then removed upon transfer of the patient to other areas ofthe hospital.

The IV set system of the present disclosure can further comprise amanifold design that provides solutions to the problems discussed above.The unique manifold design of the present disclosure overcomes problemsof current manifolds by being mounted externally to the primary IV set,thus establishing a bypass flow line to the segment of primary linewhere it is attached, such as a segment of the primary flow line. Thisbypass design serves to create an alternate primary flow path to theprimary flow line through the manifold and the bypass flow line that isoutside of or out of line from the regular primary flow path in theprimary flow line, that facilitates administration of multiple bolusesthrough the manifold either by injection or other acceptable means. Bydirectly delivering the bolus into the primary line carrier fluid, fluidtrapping within the manifold is prevented, ensuring that the entirebolus is delivered to the patient. This externally mounted manifoldbypass design will allow for the manifold to be added to the primary IVset by the attending medical personnel whenever it is deemed necessaryand will further allow the manifold to be removed when its presence isunwanted or no longer needed.

With reference to FIG. 7A, illustrated is an IV set system having aprimary line 500, a primary flow line 508, and secondary lines 516 and518, these being similar in form and function to those described above.The IV set system of FIG. 7A can further comprise marking indicia,separably joined IV sets (such as via attachment members 560), and amerging fluid pathway as set forth and described in any of theembodiments discussed herein, as will be recognized and as can beapplied by one of ordinary skill in the art.

The IV set system further comprises a manifold 540 operable with theprimary IV set 500, in accordance with one example of the presentdisclosure. Access ports 510 on the primary IV set 500 can be used toremovably and externally couple the manifold 540 in a lateral mannerrelative to the primary IV set 500. The manifold 540 can beprefabricated into or otherwise formed and made operable with theprimary flow line 508. Access ports 564 (e.g., n number of access ports)for use with syringes, secondary IV sets and other possible supportingflow lines can be formed or provided in the manifold 540 in a similarmanner as the access ports 510 formed in the primary IV set 500. Theprimary IV set 500 can further comprise access ports 510, some of whichcan be referred to as manifold access ports, that are operable toremovably couple corresponding access points on the manifold 540. In theembodiment shown, access ports 510 a and 510 b function as the accessports on the primary IV set 500 used to laterally couple the manifold540. The access points on the manifold 540 can comprise threaded portadaptors or other connector types 544 and 561 that removably couple tothe access ports 510 a (manifold input access port) and 510 b (manifoldoutput access port), respectively. The access points on the manifold 540can be spaced apart to match the respective positions of the accessports 510 a and 510 b on the primary IV set 500. In this embodiment, theattending medical personnel can make a spontaneous decision to apply amanifold bypass flow line if it is needed. No structural adaptation ofthe IV set system is required, other than clipping or otherwise couplingthe manifold device 540 to the respective access ports 510 on theprimary line 500, and particularly the primary flow line 508. Similarly,the manifold 540 can be disconnected when the bypass flow line is nolonger needed; wherein fluid flow through the primary flow line of theprimary IV set 500 is restored. The bypass design also eliminates therequirement to “break” or completely disconnect the IV set system, thusreducing the contamination and infection risk. Accordingly, theadaptation of the primary flow line with a manifold bypass attachmentstructure greatly enhances both convenience and safety, as compared withprior art practices utilizing an inline manifold configuration. In oneaspect, the manifold 540 can be prefabricated.

For most patients a hospital encounter is a multi-departmentalexperience. As a patient travels from one department to another, patientneeds and provider focuses change. The present IV set system allows easytransition from one department to the next and adapts to changingpatient needs and staff requirements. An important advantage of thepresent IV set system and its removably coupleable bypass manifold 540over current manifold systems is the referenced ability to spontaneouslyadd and remove the manifold 540 to/from the IV flow path or fluidpathway without interrupting or interfering with IV function, andparticularly the primary flow path, making it readily adaptable to mostpatient settings. For example, a trauma patient who is transported tothe hospital by ambulance may require the ambulance crew to quicklyestablish IV access using a present IV set system. Upon arrival at thehospital, the present IV set system could then be utilized by emergencydepartment personnel to administer medications, and fluids. Up to thispoint the presence of a manifold may be unnecessary and the added bulkto the line set could increase the risk of the IV becoming caught,tangled or pulled out during patient transfers. However, many patientsin the emergency department are transferred directly to the operatingdepartment for treatment. For reasons previously described, anesthesiaproviders often prefer the use of manifolds. With use of the present IVset system, the anesthesia or other provider could simply and quicklycouple a present manifold 540 to an IV set as needed or desired, thuscreating a bypass flow line that effectively reroutes or diverts thefluid pathway already established, without breaking it. In other words,the manifold facilitates diverting of the fluid from the primary flowline through the manifold and the bypass flow line to form an alternateprimary fluid flow path, wherein the flow of the fluid is maintained ina continuous manner and not stopped. Alternatively, and in someinstances, it may be desirable to have the IV set system preconfiguredwith the bypass manifold 540 pre-attached and ready to use. Otherwise,as indicated, upon arrival to the operating department the anesthesia orother provider could attach the externally mountable manifold 540 to theaccess ports of the IV set system without “breaking” the IV flow-path.The manifold 540 could be utilized during the pre-operative andoperative periods, and removed prior to the patient's transfer to thepost-operative, intensive care or medical/surgical unit. A comparativeexample would be a patient scheduled for an inpatient surgicalprocedure. The patient, upon arrival at the pre-surgical area, couldroutinely have IV access established. The preoperative nurse couldselect an IV set system, as described herein, with a manifold 540pre-attached allowing the manifold 540 to be utilized during inductionand maintenance of anesthesia. The manifold 540 could then be safely andeasily removed at the end of the operative period, prior to transferringthe patient to the designated post-surgical department. The self-sealingaccess ports 510 a and 510 b could be used as regular access ports inthe absence of the manifold 540.

The IV set system can further comprise a flow control valve or deviceassociated with the primary flow line of the primary IV set. The flowcontrol valve can operate to selectively divert fluid flow from theprimary flow line to the manifold and through the bypass flow line toform the alternate primary flow path, and then to restore fluid flowthrough the primary flow line of the primary IV set, such as uponremoval of the manifold from the primary IV set. In one aspect, the flowcontrol valve can comprise a clamp, such as a slide clamp, a rollerclamp, etc. In another aspect, the flow control valve can comprise astop cock on a proximal connection point on the primary line.

At a predetermined distance distal to the infusion spike 530 andproximal to the distal most access point of the primary IV set 500 andsecondary IV sets 516, 518, two threaded self-sealing access ports 510 aand 510 b can be placed continuous and in fluid communication with theprimary flow line 508 and the primary flow path. The predetermineddistance (as measured between the lower of the access ports connectingthe manifold (e.g., 510 b) and the distal most access point of theprimary IV set 500) can be, for example, between one and five feet. Inone aspect, this distance can be three feet.

The access ports 510 a, 510 b can be spaced at a predetermined distancefrom each other and, in some examples, can be part of a connectorportion oriented at a substantially 90-degree or orthogonal orientationrelative to the primary line 500. In one example, the access ports 510 aand 510 b can be part of a connector portion oriented on a 90 degree ororthogonal orientation and can comprise a female portion of a Luer Lock,with the connectors 544 and 561 on the manifold 540 comprising maleportions of a Luer Lock formed on a 90 degree orientation relative tothe primary flow line and operable to couple to the female portions ofthe Luer Lock. Other connection types or systems are contemplatedherein, and one skilled in the art will recognize that a Luer Lock typeconnection system is not intended to be limiting in any way. In oneexample, the manifold 540 can comprise first and second connectorportions of the same type, such as male-male or female-female. In otherwords, the connector portion types on the manifold 540 designed tocouple with the access ports on the primary IV set can be the same, eachbeing operable to couple to the access ports in the same manner. This isunlike prior manifold designs that are coupled in an in-lineconfiguration with the primary flow line where the connectors orconnector types are alternating.

As one skilled in the art will recognize, connection systems havingangular orientations other than 90 degrees may be employed and usedwhere merited by the circumstances, such as connector portions havingangular orientations between 30 and 150 degrees (as measured from thelongitudinal axis of the primary line 500), or even others. For example,FIG. 7B illustrates access ports 510 a′ and 510 b′, each being formed aspart of a connector portion oriented on an angle other than 90 degreesrelative to the primary flow line 108′. Specifically, access port 510 a′forms part of a connector portion oriented in a downward direction on anangle α (e.g., 120 degrees), and access port 510 b′ forms part of aconnector portion that is oriented in an upward direction at an angle β(e.g., 30 degrees). In another example, FIG. 7C illustrates access ports510 a″ and 510 b″, each being formed as part of a connector portionoriented on an angle other than 90 degrees relative to the primary flowline 108″. Specifically, access port 510 a″ forms part of a connectorportion oriented in an upward direction at an angle α (e.g., 30degrees), and access port 510 b″ forms part of a connector portion thatis oriented in downward direction at an angle β (e.g., 120 degrees). Ascan be seen, and as will be appreciated by those skilled in the art, therelative degrees of angles α and β of the access ports in the aboveexamples of FIGS. 7A-7C can range anywhere between 0 and 180 degrees).

Referring back to FIG. 7A, a flow control valve or device in the form ofa slide style clamp 512 can be placed on the primary line 500 betweenthe two access ports 510 a and 510 b. A threaded port adapter or otherconnector 544 on the manifold 540 can be connected to the proximalaccess port 510 a and can be oriented perpendicular or orthogonal to theprimary flow line 508. The port adapter 544 can then be connected to asolid 90-degree angle or other angular orientation connector 548 on themanifold 540, which can divert the flow path through the manifold 540 ina direction parallel to the primary flow line 508 of the primary IV set500. The flow can continue distal to the 90-degree or other angularorientation connector 548 along a solid manifold or bypass line 552(e.g., the bypass flow line), which can continue parallel to the primaryIV set 500. The solid manifold or bypass line 552 can comprise one ormore access ports 564 that function similar to the access ports 510 onthe primary IV set 500.

Lateral to the distal self-sealing access port 510 b can be a second90-degree or other angular orientation connector 556 on the manifold 540attached to the primary IV set 500 via a threaded port adaptor or otherconnector 561 that can be connected to the distal self-sealing accessport 510 b of the primary IV set 500. When the manifold 540 is connectedto the primary IV set 500, the slide clamp 512 can be closed to occludethe primary flow line 508 in-between the two self-sealing access ports510 a and 510 b. This will divert flow from the primary flow line 508,through the proximal self-sealing access port 510 a and through themanifold 540, thus creating or thrilling an alternate primary fluid flowpath. The flow can then continue through the manifold or bypass flowline, then through the distal self-sealing access port 510 b and thenback into the primary flow line where it will continue through thedistal portion of the primary flow line 508 until it terminates at theIV patient interconnect. When the manifold 540 is not needed it can beremoved and the slide clamp 512 opened to allow direct flow through theprimary flow line 508.

The advantages of the present manifold and the formed bypass over theprior art are significant. The ability to add and remove the manifoldwill allow for a quick, safe and effective method of patient centered,interdepartmental IV adaption. This adaptability will reduce the need tochange the entire IV set system as the patient's treatment, department,or status changes. This can result in a decrease in treatment costs andmedical waste. Addition and removal of the manifold can be done byentering, but not separating the primary flow path. This will increasepatient safety by reducing the risk of exposure to contaminants orinfective agents during addition or removal of the manifold apparatus.

It will be apparent to those skilled in the art that the presentinvention can be viewed as a total or complete IV system in which thecomponents and features discussed herein, in any of the embodiments, canbe combined and cooperate together to provide an IV set system having alevel of safety, performance, and convenience within the medical field,unlike current, mere compilations of IV sets. For instance, an exemplaryintravenous (IV) set system can comprise, in combination, a primary IVset having a plurality of access points facilitating access to one ormore fluid pathways of the primary IV set, and top-level markingindicia; a secondary IV set removably coupleable with the primary IV setvia one of the access points of the primary IV set, the secondary IV setcomprising a plurality of access points facilitating access to one ormore fluid pathways of the secondary IV set, and marking indicia thatdiffers from the top-level marking indicia of the primary IV set,wherein the primary and secondary IV sets are distinguishable from oneanother, wherein the secondary IV set is further separably joined to theprimary IV set in at least a semi-continuous manner substantially alongits length to inhibit entanglement with the primary IV set, and whereinthe secondary IV set is at least partially strippable from the primaryIV set; a manifold operable to externally removably couple to theprimary IV set via the plurality of access points, the manifoldcomprising a bypass flow line forming an alternate primary flow path toa fluid pathway of the primary IV set; a merging fluid pathway locatedabout the primary IV set and comprising one or more access ports,wherein the at least one secondary IV set is fluidly coupleable to oneof the access ports of the merging fluid pathway, such that a fluid flowpath of the secondary IV set merges with a fluid flow path of theprimary IV set.

The IV set system of the present invention as discussed herein providesinteractive and synergistic features that offer a significant stepforward over prior IV sets or compilations of IV sets. Furthermore, eachinventive component as described above can be viewed as a separateinvention that can be applied within other fields of use independent ofthe whole. Several examples of such allocations and procedures have beenset forth above and need no further explanation.

The foregoing structures and descriptions can also be applied withrespect to procedures and methods of administering an IV to a patientwith the benefit of reducing risk of error. Specifically, the methodprovides selective identification of at least one IV set defining atleast one flow line within an IV set system which includes (i) a primaryIV set having a proximal terminus, a distal terminus, and anintermediate tubular length defining a primary flow line of the primaryIV set and (ii) at least one secondary IV set defining at least onesecondary flow line configured to feed to the primary flow line of theprimary IV set, the at least one secondary IV set having a proximalterminus, a distal terminus, and an intermediate tubular length. Therepresentative steps of the method can include (a) applying at least onecommon set of unique marking indicia, which can also be uniform, to atleast one of the primary and/or secondary IV sets to enable rapididentification thereof with respect to other lines of the IV set system;and (b) allocating or associating the at least one primary and/orsecondary IV sets having the unique marking indicia to/with a primaryfunction or primary user as part of a medical procedure, therebyproviding notice to other attending medical personnel of the allocatedfunction for the at least one primary IV set and/or secondary IV sets.Several examples of such allocations and procedures have been set forthabove and need no further explanation.

The following examples illustrate several options for applying thedisclosed features in greater detail. For example, the method mayfurther comprise the steps of (i) applying the unique marking indicia(which may also be uniform) to a plurality of access points/portspositioned along the primary IV set of the IV set system to identify theprimary IV set from other lines of the IV set system, and (ii)allocating the primary flow line with the function of providing the IVwith a primary carrier fluid flow line. Furthermore, secondary IV setsmay also be marked and identified in a similar manner. For example, themethod may also include the steps of (i) applying the unique markingindicia (which may also be uniform) to at least one of the secondary IVsets, including at least the distal terminus of the secondary IV set,for identification thereof from other lines of the IV set system and(ii) allocating the secondary flow line to the function of providing aninfusion flow path into the primary flow line.

It will be apparent that the IV set system and the methods ofadministering a patient IV disclosed above can be practiced in numerouscombinations with selective identification of some or all IV sets of theIV set system being appropriately marked to facilitate identification ofselected IV sets through multiple stages of patient care.

A further a general method is disclosed for providing access for bolusinjections and/or secondary IV sets to a primary flow line of a primaryIV set using an external bypass manifold having at least one accessport. This step can be taken without breaking the primary fluid flowline of the primary IV set and the fluid flow to a patient, but ratherby diverting such primary fluid flow. The steps of this procedure caninclude a) coupling a first proximal end of the manifold to a segment ofthe primary IV set through an access port on the primary IV set thatcommunicates directly with the primary flow line and the fluid flow paththerein. The method can further comprise b) positioning the manifoldadjacent to and aligned with the segment of the primary IV set, and c)coupling the second distal end of the manifold to the segment of theprimary IV set through another access port on the primary IV set thatalso communicates directly with the primary flow line and the fluid flowpath therein. Laterally coupling the manifold in this manner effectivelyestablishes a bypass flow line external and adjacent to the primary flowline (e.g., out of line rather than in-line) of the primary IV set. Themethod can further comprise d) blocking flow through the primary flowline within the segment of the primary IV set, thereby diverting fluidflow and the fluid flow path through the bypass line created by themanifold. The method can further comprise e) coupling a fluid deliverydevice, such as a syringe or a secondary line, to an access port of themanifold to enable fluid flow into the manifold bypass line, such as toadminister fluids (e.g., medication, analgesics, etc.) to the patient.

It is to be understood that the embodiments of the invention disclosedare not limited to the particular structures, process steps, ormaterials disclosed herein, but are extended to equivalents thereof aswould be recognized by those ordinarily skilled in the relevant arts. Itshould also be understood that terminology employed herein is used forthe purpose of describing particular embodiments only and is notintended to be limiting.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment of the present invention. Thus, appearancesof the phrases “in one embodiment” or “in an embodiment” in variousplaces throughout this specification are not necessarily all referringto the same embodiment.

As used herein, a plurality of items, structural elements, compositionalelements, and/or materials may be presented in a common list forconvenience. However, these lists should be construed as though eachmember of the list is individually identified as a separate and uniquemember. Thus, no individual member of such list should be construed as ade facto equivalent of any other member of the same list solely based ontheir presentation in a common group without indications to thecontrary. In addition, various embodiments and example of the presentinvention may be referred to herein along with alternatives for thevarious components thereof. It is understood that such embodiments,examples, and alternatives are not to be construed as de factoequivalents of one another, but are to be considered as separate andautonomous representations of the present invention.

Furthermore, the described features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments. In thedescription, numerous specific details are provided, such as examples oflengths, widths, shapes, etc., to provide a thorough understanding ofembodiments of the invention. One skilled in the relevant art willrecognize, however, that the invention can be practiced without one ormore of the specific details, or with other methods, components,materials, etc. In other instances, well-known structures, materials, oroperations are not shown or described in detail to avoid obscuring;aspects of the invention.

While the foregoing examples are illustrative of the principles of thepresent invention in one or more particular applications, it will beapparent to those of ordinary skill in the art that numerousmodifications in form, usage and details of implementation can be madewithout the exercise of inventive faculty, and without departing fromthe principles and concepts of the invention.

The invention claimed is:
 1. A manifold for use with an intravenous (IV)set system, comprising: a manifold body defining, at least in part, abypass flow line; a first connector portion at a proximal end of themanifold body, the first connector portion operable to couple to a firstaccess port of a primary IV set of an IV set system; a second connectorportion at a distal end of the manifold body, the second connectorportion operable to couple to a second access port of the primary IVset; one or more access points situated along the manifold body and thatfacilitate fluid access to the bypass flow line, wherein the bypass flowline provides an alternate primary flow path to a primary flow paththrough a primary flow line of the primary IV set when the manifold iscoupled to the primary IV set.
 2. The manifold of claim 1, wherein thefirst and second connector portions are externally coupleable to thefirst and second access portions of the primary IV set.
 3. The manifoldof claim 1, wherein the first and second connector portions eachcomprise a ninety degree connector.
 4. The manifold of claim 1, whereinthe first and second connector portions each comprise a male connector.5. The manifold of claim 1, wherein the first and second connectorportions each comprise a female connector.
 6. The manifold of claim 1,wherein the first and second connector portions are each oriented on anangle relative to the primary flow line upon the manifold being coupledto the primary IV set.
 7. The manifold of claim 1, wherein the firstconnector portion is oriented on an upward angle, and wherein the secondconnector portion is oriented on a downward angle, the upward anddownward angles being relative to the primary flow line, upon themanifold being coupled to the primary IV set.
 8. The manifold of claim1, wherein the first connector portion is oriented on a downward angle,and wherein the second connector portion is oriented on an upward angle,the upward and downward angles being relative to the primary flow line,upon the manifold being coupled to the primary IV set.
 9. The manifoldof claim 1, wherein at least a portion of the manifold body is operableto be oriented substantially parallel to the primary flow line when themanifold is coupled to the primary IV set.
 10. The manifold of claim 1,wherein the manifold body is externally coupleable to the primary IVset, such that the manifold is operable to divert the primary flow pathwithout breaking the primary flow line of the primary IV set.
 11. Anintravenous (IV) set system, comprising: a primary IV set having aprimary flow line and a plurality of access points comprising accessports providing fluid access to the primary flow line, and a IV patientinterconnect; a manifold removably coupleable to the primary IV set viaat least some of the access ports of the primary IV set, the manifolddefining a bypass flow line, and one or more access points thatfacilitate access to the bypass flow line, a flow control valveassociated with the primary flow line of the primary IV set, the flowcontrol valve being operable to be closed to divert fluid flow from theprimary flow line to the manifold and through the bypass flow line toform an alternate primary flow path to a primary flow path through theprimary flow line, and the flow control valve being operable to beopened to restore fluid flow through the primary flow line of theprimary IV set, wherein, in operation, the manifold and the bypass flowline operate to facilitate the maintenance of a flow of fluid in acontinuous manner to the IV patient interconnect.
 12. The IV set systemof claim 11, wherein at least some of the plurality of access ports ofthe primary IV set are self-sealing, and wherein at least twoself-sealing access ports are adjacent one another on the primary flowline of the primary IV set, wherein the manifold is removably coupleableto the adjacent self-sealing access ports.
 13. The IV set system ofclaim 12, wherein the flow control valve is located between the adjacentself-sealing access ports.
 14. The IV set system of claim 13, wherein atleast a portion of the bypass flow line is oriented substantiallyparallel to the primary flow line when the manifold is coupled to theprimary IV set.
 15. The IV set system of claim 13, wherein the manifoldis externally coupleable to the primary IV set, such that the manifoldis operable to divert the primary flow path without breaking the primaryflow line of the primary IV set.
 16. The IV set system of claim 11,wherein the manifold comprises first and second connector portionscoupleable to respective first and second access ports of the primary IVset.
 17. The IV set system of claim 16, wherein the first and secondconnector portions comprise connectors of the same type.
 18. The IV setsystem of claim 16, wherein the first and second connector portions areeach oriented on an angle relative to the primary flow line.
 19. The IVset system of claim 16, wherein the first connector portion is orientedon an upward or a downward angle relative to the primary flow line, andwherein the second connector portion is oriented on an upward or adownward angle relative to the primary flow line.
 20. A method of makinga manifold for use with an intravenous (IV) set system, comprising:forming a manifold body defining, at least in part, a bypass flow line;forming a first connector portion at a first end of the manifold body,the first connector portion comprising a quick connect and disconnectinterface to facilitate removably coupling of the first connectorportion to a first access port of the primary IV set; forming a secondconnector portion at a second end of the manifold body, the secondconnector portion comprising a quick connect and disconnect interface tofacilitate removably coupling of the second connector portion to asecond access port of the primary IV set; and forming one or more accesspoints along the manifold body, wherein the one or more access pointsfacilitate fluid access to the bypass flow line, such that the bypassflow line operates to provide an alternate primary flow path to aprimary flow path through a primary flow line of the primary IV set uponthe manifold being coupled to the primary IV set.
 21. The method ofclaim 20, wherein the first connector portion is oriented on an upwardor a downward angle relative to a portion of the manifold body, andwherein the second connector portion is oriented on an upward or adownward angle relative to the portion of the manifold body.
 22. Themethod of claim 20, wherein the first and second connector portions areexternally coupleable to the primary IV set, and wherein the first andsecond connector portions comprise connectors of the same type.